CA2834618C - Formulation de vaccin contre le papillomavirus comprenant un adjuvant a l'aluminium, et procede de production correspondant - Google Patents

Formulation de vaccin contre le papillomavirus comprenant un adjuvant a l'aluminium, et procede de production correspondant Download PDF

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Publication number
CA2834618C
CA2834618C CA2834618A CA2834618A CA2834618C CA 2834618 C CA2834618 C CA 2834618C CA 2834618 A CA2834618 A CA 2834618A CA 2834618 A CA2834618 A CA 2834618A CA 2834618 C CA2834618 C CA 2834618C
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hpv
formulation
formulations
buffer
vlps
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CA2834618A1 (fr
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Akhilesh Bhambhani
Ramesh V. Chintala
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Merck Sharp and Dohme LLC
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Merck Sharp and Dohme LLC
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/39—Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/20—Antivirals for DNA viruses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/525—Virus
    • A61K2039/5258—Virus-like particles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55505—Inorganic adjuvants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/70—Multivalent vaccine
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2710/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
    • C12N2710/00011—Details
    • C12N2710/20011—Papillomaviridae
    • C12N2710/20023—Virus like particles [VLP]
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2710/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
    • C12N2710/00011—Details
    • C12N2710/20011—Papillomaviridae
    • C12N2710/20034—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Virology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Biotechnology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Biomedical Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne des formulations d'antigènes du papillomavirus ou "HPV" (Human Papillomavirus) présentant une stabilité accrue des antigènes. L'invention concerne plus particulièrement des formulations anti-HPV stables comprenant, d'une part des pseudo-particules virales du HPV liées à un adjuvant à base de sels d'aluminium, mais aussi une combinaison de sucrose et de mannitol. Les formulations vaccinales de l'invention s'avèrent stables après congélation-décongélation et lyophilisation. L'invention concerne également des formulations vaccinales anti-HPV lyophilisées et congelées comprenant des pseudo-particules virales du HPV d'au moins un type de HPV adsorbées sur un adjuvant à base de sels d'aluminium, de sucrose et de mannitol. L'invention concerne également des procédés de fabrication des formulations vaccinales stables de l'invention.
CA2834618A 2011-06-24 2012-06-22 Formulation de vaccin contre le papillomavirus comprenant un adjuvant a l'aluminium, et procede de production correspondant Active CA2834618C (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161500829P 2011-06-24 2011-06-24
US61/500,829 2011-06-24
PCT/US2012/043694 WO2012177970A1 (fr) 2011-06-24 2012-06-22 Formulation de vaccin contre le papillomavirus comprenant un adjuvant à l'aluminium, et procédé de production correspondant

Publications (2)

Publication Number Publication Date
CA2834618A1 CA2834618A1 (fr) 2012-12-27
CA2834618C true CA2834618C (fr) 2020-11-03

Family

ID=47422963

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2834618A Active CA2834618C (fr) 2011-06-24 2012-06-22 Formulation de vaccin contre le papillomavirus comprenant un adjuvant a l'aluminium, et procede de production correspondant

Country Status (9)

Country Link
US (2) US20140127260A1 (fr)
EP (1) EP2723371B1 (fr)
JP (1) JP6050811B2 (fr)
KR (1) KR102049988B1 (fr)
AU (1) AU2012272788B2 (fr)
CA (1) CA2834618C (fr)
ES (1) ES2762230T3 (fr)
RU (1) RU2610174C2 (fr)
WO (1) WO2012177970A1 (fr)

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WO2015100344A1 (fr) * 2013-12-27 2015-07-02 Emergent Product Development Gaithersburg Inc. Formulations de vaccin thermostables
US20170212116A1 (en) 2014-01-31 2017-07-27 Ulisse Biomed Srl Biosensors for the detection of infection and associated maladies
EP3139952A1 (fr) * 2014-05-06 2017-03-15 The Regents of the University of Colorado, a body corporate Compositions, procédés et utilisations pour formulations de papillomavirus thermiquement stables
US11273127B2 (en) 2014-05-06 2022-03-15 The Regents Of The University Of Colorado, A Body Corporate Compositions, methods and uses for thermally stable multi-targeted antigens
CN107002085A (zh) * 2014-09-11 2017-08-01 卡迪拉保健有限公司 具有优异免疫学特性的优异的人乳头瘤病毒抗原和含有其的疫苗
AU2016221318B2 (en) * 2015-02-19 2020-06-25 Pfizer Inc. Neisseria meningitidis compositions and methods thereof
WO2017041083A1 (fr) 2015-09-04 2017-03-09 Inventprise, Llc Compositions de vaccin stabilisés de vlp
CN105999260B (zh) 2016-05-13 2019-12-10 四川大学 氢氧化铝凝胶-氯化钠复合免疫佐剂及其制备方法和用途
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US11166915B2 (en) 2016-09-16 2021-11-09 Leukocare Ag Method for obtaining efficient viral vector-based compositions for vaccination or gene therapy
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US20240075124A1 (en) * 2021-01-14 2024-03-07 Sinocelltech Ltd Stable formulation of human papillomavirus virus-like particle vaccine
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Also Published As

Publication number Publication date
EP2723371A4 (fr) 2015-01-21
EP2723371A1 (fr) 2014-04-30
JP6050811B2 (ja) 2016-12-21
CA2834618A1 (fr) 2012-12-27
US20170157238A1 (en) 2017-06-08
AU2012272788B2 (en) 2016-10-20
WO2012177970A1 (fr) 2012-12-27
RU2014102200A (ru) 2015-07-27
US10772947B2 (en) 2020-09-15
ES2762230T3 (es) 2020-05-22
US20140127260A1 (en) 2014-05-08
EP2723371B1 (fr) 2019-10-23
KR20140036244A (ko) 2014-03-25
KR102049988B1 (ko) 2019-11-28
JP2014520160A (ja) 2014-08-21
RU2610174C2 (ru) 2017-02-08
AU2012272788A1 (en) 2013-11-07

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